Rotation actuator for endoscopic devices

ABSTRACT

Methods and devices are provided for rotating an end effector on a long, flexible medical device. The methods and devices utilize an actuator mechanism that is effective to rotate an end effector on the distal end of an elongate flexible shaft. The actuator mechanism is movable between a freely rotatable position and a rotationally resistant position. When the actuator mechanism is in a freely rotatable position, the actuator mechanism can be rotated to impart torque to the end effector, and thus at least a distal portion of the elongate shaft, to cause the end effector to rotate. In order to prevent the actuator mechanism from “freewheeling,” wherein the actuator mechanism freely rotates in an opposite direction upon release rather than the end effector rotating in the desired direction, the actuator mechanism can be moved to the rotationally resistant position.

FIELD OF THE INVENTION

The present invention relates to broadly to surgical devices, and inparticular to methods and devices for rotating an end effector on asurgical device.

BACKGROUND OF THE INVENTION

Recently, many surgical devices have been made flexible for use inendoscopic procedures, allowing the devices to be inserted through aworking channel of an endoscope. The ability to grasp tissue, applyfasteners, or perform various other procedures through an endoscopepermits myriad minimally invasive surgical solutions to medicalproblems, especially those of the gastrointestinal tract.

Some endoscopic surgical devices include a flexible tubular shaft, acontrol member longitudinally movable relative to the tubular shaft, anend effector coupled to the distal ends of the tubular member and thecontrol member, and a housing with controls for actuating the controlmember. Actuation of the control member relative to the tubular membercauses operation of the end effector, which can be, for example, a pairof opposed tissue-effecting jaws. Some devices are also configured suchthat rotation of the control member can be effective to rotate the endeffector.

One drawback of current endoscopic surgical devices resides in thedifficulty to rotate the end effector. As mentioned above, rotation of acontrol member can rotate the end effector. This can be achieved byapplying torque to the distal end of the tubular shaft to thereby rotatethe shaft and thus rotate the end effector coupled thereto. For example,a knob coupled to the proximal end of the control member can be rotatedto rotate the control member, and thereby rotate the tubular shaft andend effector. The knob is rotationally coupled to the control member andis allowed to freewheel; that is, the knob spins freely, providingminimal rotational resistance. Often, multiple turns of the knob arenecessary to rotate the end effector a desired amount, as the rotationangle of the knob is greater than the corresponding rotation of the endeffector because of the angular deformation of the control member due toits relatively long length and small diameter and also due to thetorsional resistances provided by the shaft. When the user rotates theknob, the control member twists until the resistance torque is overcome,eventually causing the tubular shaft to rotate and thereby rotate theend effector. However, release of the knob between turns would allow thecontrol member to un-twist, driving itself and the knob, as the knob isrotationally coupled to the control member and provides littlerotational resistance, to a neutral energy state (state of zero or nearzero angular deflection). As a result, the user must keep at least afinger on the knob to prevent the control member from unwinding as theyimpart successive rotations to the knob. This can be difficult toachieve comfortably and with only one hand, which is often necessaryduring surgical procedures.

Accordingly, there remains a need for improved methods and devices forrotating an end effector on an endoscopic surgical device.

SUMMARY OF THE INVENTION

The present invention provides various methods and devices for rotatingan end effector on an endoscopic surgical device. In one embodiment, anendoscopic device is provided and includes a flexible elongate shafthaving proximal and distal ends, an end effector coupled to the distalend of the elongate shaft, and a housing coupled to the proximal end ofthe elongate shaft. The housing can include an actuator mechanismassociated with a distal end of the elongate shaft such that rotation ofthe actuator mechanism is effective to rotate the distal end of theelongate shaft and thereby rotate the end effector. The actuatormechanism can be movable between a freely rotatable position and arotationally resistant position, in which the actuator mechanism isresistant to rotation.

While the actuator mechanism can have a variety of configurations, inone embodiment the actuator mechanism can be a rotatable knob. Therotatable knob can be rotatably disposed within an opening formed in thehousing and it can be slidably movable relative to the housing along alongitudinal axis of the device. Sliding movement of the knob along thelongitudinal axis can be effective to move the knob between the freelyrotatable position and the rotationally resistant position. The housingcan also include an engagement mechanism formed therein and configuredto releasably engage a portion of the knob when the knob is in therotationally resistant position. In one embodiment, the engagementmechanism can be a flange formed within the housing and configured tofrictionally engage a portion of the knob when the knob is in therotationally resistant position. In another embodiment, the engagementmechanism can be a flange formed within the housing and configured toengage detents formed on a portion of the knob when the knob is in therotationally resistant position. In another aspect, the rotatable knobcan include a deformable element and the housing can include an openinglocated therein and configured to receive and engage the deformableelement to maintain the actuator mechanism in the rotationally resistantposition.

The actuator mechanism can also have a variety of configurations, and inone embodiment the actuator mechanism can include a shaft having atleast an end portion that is split into first and second halves. Thehousing can include an opening located therein and configured to receiveand engage the first and second halves to maintain the actuatormechanism in the rotationally resistant position. In one exemplaryembodiment, at least one of the first and second halves includes atleast one surface feature formed thereon, and the opening includes atleast one groove formed therein and configured to receive the at leastone surface feature to appropriately resist rotation of the actuatormechanism.

In another embodiment, the actuator mechanism and the distal end of theelongate shaft can be associated by a flexible control wire extendingthrough the elongate shaft between the actuator mechanism and the distalend of the elongate shaft. Rotation of the actuator member can beeffective to torque the flexible control wire and thereby torque theelongate shaft to rotate the end effector.

The device can also include other features, such as a biasing elementcoupled to the actuator mechanism and adapted to bias the actuatormechanism to the freely rotatable position. In another embodiment, thehousing can include a grasping mechanism movably coupled thereto, andmovement of the grasping mechanism from a first position to a secondposition can be configured to move the actuator mechanism from therotationally resistant position to the freely rotatable position. Inother aspects, the end effector can include opposed jaws and movement ofthe grasping mechanism from the first position to the second positioncan be effective to close the opposed jaws.

In yet another embodiment, a surgical fastener applying device isprovided and includes a flexible elongate shaft having proximal anddistal ends, an end effector coupled to the distal end of the elongateshaft and including opposed jaws adapted to engage tissue therebetweenand to apply at least one fastener to the engaged tissue, and a housingcoupled to the proximal end of the elongate shaft and having an actuatormechanism rotatably coupled thereto. The actuator mechanism can beslidably movable between a first position, in which rotation of theactuator mechanism is effective to rotate a distal end of the elongateshaft to thereby rotate the end effector, and a second position, inwhich the actuator mechanism is resistant to rotation, i.e.,rotationally resistant.

The housing can have a variety of configurations, but in one embodimentthe housing can include an engagement mechanism formed therein andconfigured to releasably engage the actuator mechanism to maintain theactuator mechanism in the second position. The housing can also includea grasping mechanism movably coupled thereto and configured to move theactuator mechanism from the second position to the first position.

In yet another embodiment, a method for rotating an end effector on anendoscopic surgical device is provided and includes rotating an actuatormechanism on a housing of an endoscopic surgical device to rotate adistal end of an elongate shaft extending from the housing. The distalend of the elongate shaft can have an end effector coupled thereto thatrotates therewith. The method can further include sliding the actuatormechanism along a longitudinal axis of the device to move the actuatormechanism to a rotationally resistant position, wherein the actuatormechanism, elongate shaft, and end effector are maintained in a rotatedposition. In an exemplary embodiment, the endoscopic surgical device isinserted through a body lumen.

In another embodiment, the distal end of the elongate shaft and actuatormechanism can be coupled by a flexible control wire, and rotating theactuator mechanism can torque the flexible control wire to cause thedistal end of the elongate shaft and the end effector coupled thereto torotate. The actuator can also be slid in an opposite direction along alongitudinal axis of the device to move the actuator mechanism to afreely rotatable position, in which any torque on the flexible controlwire is released. The method can also include moving a graspingmechanism coupled to the housing to move the actuator mechanism from therotationally resistant position to a freely rotatable position.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side view of one exemplary embodiment of a surgical clipapplier;

FIG. 2 is a side view of an end effector of the surgical clip applier ofFIG. 1;

FIG. 3 is side view of a housing of the surgical clip applier of FIG. 1with a portion of the housing removed to expose internal controlcomponents;

FIG. 4 is a partially transparent side view of a distal portion of ashaft of the device of FIG. 1, showing first and second control wires, acoupler, pull wires for moving the jaws, and a clip advancing mechanism;

FIG. 5 is a perspective view of a distal portion of the clip advancingmechanism of FIG. 4;

FIG. 6A is a perspective view of a knob of the housing shown in FIG. 3;

FIG. 6B is a side view of a proximal portion of a flexible control wirefor use with the knob of FIG. 6A;

FIG. 6C is a cross-sectional view of an opening formed in the housingshown in FIG. 3;

FIG. 6D is a side perspective view of a portion of the housing of FIG.3, with a portion of the housing removed to show the knob of FIG. 6Adisposed therein;

FIG. 6E is a side view of the portion of the housing shown in FIG. 6D,with the knob moved to a rotationally resistant position;

FIG. 6F is a side view of the portion of the housing shown in FIG. 6E,with a trigger pivoted to release the knob from the rotationallyresistant position;

FIG. 7A is a perspective view of another embodiment of a knob for usewith the housing of the device shown in FIG. 3;

FIG. 7B is a side view of a portion of a housing having a portion of thehousing removed to show the knob of FIG. 7A disposed therein;

FIG. 7C is a side view of the portion of the housing shown in FIG. 7B,with the knob moved to a rotationally resistant position; and

FIG. 7D is a side view of the portion of the housing shown in FIG. 7C,with a trigger pivoted to release the knob from the rotationallyresistant position.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention generally provides methods and devices forrotating an end effector on a long, flexible medical device. The methodsand devices utilize an actuator mechanism that is effective to rotate anend effector on the distal end of an elongate flexible shaft, and thatis movable between a freely rotatable position and a rotationallyresistant position. When the actuator mechanism is in a freely rotatableposition, the actuator mechanism can be rotated to impart torque to adistal portion of the elongate shaft, thereby rotating the end effector.In order to maintain the actuator mechanism and thus the end effector inthe rotated position, and to prevent the actuator mechanism from“freewheeling,” wherein the actuator mechanism freely rotates in anopposite direction upon release rather than the end effector rotating inthe desired direction, the actuator mechanism can be moved to therotationally resistant position. The rotationally resistant position isa position in which the actuator mechanism is resistant to rotation suchthat free rotation or “freewheeling” is prevented, yet the resistance torotation is preferably low enough to still allow a user to rotation theactuation mechanism (and, thereby, rotationally position the endeffector). This is particularly advantageous with endoscopic deviceswhich have a relatively long shaft through which the rotational forcesmust be transferred to rotate the end effector. Moreover, therotationally resistant position is particularly useful where theactuator mechanism must be rotated several turns to position the endeffector as desired. In such a situation, the engagement mechanism willprevent the actuator mechanism from “freewheeling” between turns inwhich the user needs to release and re-grasp the actuator mechanism.

A person skilled in the art will appreciate that, while the methods anddevices are described in connection with an endoscopic clip applier, theconcepts can be applied to a variety of other surgical, therapeutic, ordiagnostic devices in which it is desirable to rotate an end effector.Moreover, the present invention has application in conventionalendoscopic and open surgical instrumentation, as well application inrobotic-assisted surgery. A person skilled in the art will alsoappreciate that, while the actuator mechanism is described as having arotational resistant position, in other embodiments the rotationallyresistant position can be one in which the actuator mechanism is lockedand is prevented from rotating all together. The amount of resistant canbe configured as may be necessary depending on the intended use.

FIG. 1 illustrates one exemplary embodiment of an endoscopic devicehaving an actuator mechanism for controlling rotation of an endeffector. While the actuator mechanism can be used with a variety ofdevices having end effectors for performing various procedures, such asfastening, manipulating, and treating tissue, FIG. 1 illustrates aflexible clip applier 10. As shown, the clip applier 10 generallyincludes a flexible elongate shaft 12 having a proximal end 12 a coupledto a housing 20, and a distal end 12 b with an end effector 30 coupledthereto. The end effector 30 includes opposed jaws 32 a, 32 b that areconfigured to engage tissue therebetween, and to apply a clip to thetissue.

The housing 20 can have a variety of configurations, but it preferablyincludes at least one handle to facilitate grasping of the device.Various handle assemblies known in the art can be used including, forexample, spool style handles, syringe style handles, and various otherhandle configurations. In the illustrated embodiment, the housing 20includes a pivoting trigger or lever style handle. In particular, thehousing 20 is a generally pistol-shaped with a stationary handle 22extending from a bottom surface thereof. A trigger 24 is pivotallycoupled to the housing 20 and it is effective to pivot toward thestationary handle 22 to close opposed jaws 32 a, 32 b of the endeffector. The housing 20 also includes a rotatable knob 26 which iseffective to rotate the end effector 30, as well as a crank 28 which iseffective to advance a clip through the shaft 12 and into the jaws 32 a,32 b of the end effector 30. The three actuator mechanisms, i.e., thetrigger 24, rotatable knob 26, and crank 28, will be discussed in moredetail below.

The elongate shaft 12 that extends from the housing 20 can have avariety of configurations, but in an exemplary embodiment it is flexibleor semi-flexible to allow the elongate shaft 12 to be introducedtranslumenally, e.g., through a natural orifice. While various materialsand techniques can be used to form a flexible shaft, in the illustratedembodiment the elongate shaft 12 is formed form a friction reducingflexible outer sheath having a flat coil wire extending therethrough.The flexibility of the shaft 12 can vary along different portions of theshaft 12, and the shaft 12 can also be formed from one or morecomponents that are mated together. In certain exemplary embodiments, aswill be discussed in more detail below, the shaft 12 can include aflexible proximal portion and a distal portion that can be substantiallyrigid or that can have a similar or greater flexibility than theproximal portion. The distal portion can extend distally from a coupler,which will be discussed below, and it can connect to the end effector30. In use, when the rotatable knob 26 is rotated to rotate the endeffector 30, at least a distal region of the flexible proximal portionof the shaft 12 will twist to rotate the distal portion of the shaft 12,thereby rotating the end effector 30.

The end effector 30 coupled to the distal end 12 b of the elongate shaft12 can also have a variety of configurations, and one exemplaryembodiment of an end effector 30 is shown in more detail in FIG. 2. Asshown, the end effector 30 includes a jaw mount or clevis 34 that matesto the distal end 12 b of the elongate shaft 12. First and second jaws32 a, 32 b are pivotally mated to the clevis 34 via a mounting hole(only one mounting hole 35 is shown), and each jaw 32 a, 32 b includes aproximal tang (only one tang 33 b is shown) that is coupled to a pullwire (only one pull wire 38 b is shown) which extends through a distalportion of the elongate shaft 12 and mates to a coupler, as will bediscussed in more detail below. Proximal axial movement of the pullwires is effective to close the opposed jaws 32 a, 32 b and therebygrasp tissue positioned therebetween, and distal movement of the pullwires is effective to open the opposed jaws 32 a, 32 b. The end effector30 is also configured to apply a plurality of clips, sequentially, totissue engaged between the jaws. This can be achieved using a clipadvancing assembly, discussed in more detail below, which advances aclip into the jaws, and an anvil formed within each jaw 32 a, 32 b fordeforming the clip.

As indicated above, the housing 20 includes three actuator mechanisms, atrigger 24 for opening and closing the jaws 32 a, 32 b, a rotatable knob26 for rotating the end effector 30, and a crank 28 for advancing a clipinto the jaws 32 a, 32 b. FIGS. 2, 3, and 4 illustrate the trigger 24and jaw closing assembly, FIGS. 3 and 4 illustrate the rotatable knob 26and end effector rotation assembly, and FIGS. 1, 3, 4, and 5 illustratethe crank 28 and clip advancing assembly. The assemblies and variousexemplary configurations for each assembly are also described in moredetail in commonly owned U.S. Publication No. 2005/0277954 filed on Jun.14, 2004 and entitled “Endoscopic Clip Applier Actuator,” which ishereby incorporated by reference in its entirety.

Turning first to FIG. 3, the trigger 24 is pivotally mounted within thehousing 20 by a pivot pin 25, and includes a distal portion 24 b havinga thumb grip formed therein and a proximal extension arm 24 a. Theextension arm 24 a is coupled to a shuttle assembly 40 which movesbetween proximal and distal positions within the housing 20. The shuttleassembly 40 can have various configurations and it can include variousfeatures, such as an overload mechanism. The particular configuration ofthe shuttle assembly 40 (or linkage) is described in more detail in US.Publication No. 2005/0277954. As shown in FIG. 3, the shuttle assembly40 is coupled to a proximal portion of a first control wire 42, whichextends through the elongate shaft 12. The distal end of the firstcontrol wire 42 mates to a joiner or coupler 44, which is shown in FIG.4. The coupler 44 is positioned proximal to the end effector 30, i.e.,the clevis 34 and jaws 32 a, 32 b. The coupler 44 is also positionedproximal to the distal portion of the elongate shaft. In particular, aspreviously discussed, the elongate shaft 12 can include a flexibleproximal portion and a distal portion. The proximal and distal portionsare mated by a rigid member 48. This can be done, for example, by laserwelding both the proximal and distal portions to the rigid member 48,which is shown in FIG. 4. The coupler 44 is disposed within and mated toa distal region of the flexible proximal portion of the elongate shaft12, just proximal to the rigid member 48. This allows the coupler 48 toapply a rotational torque to the distal region of the proximal portionof the elongate shaft 12, thereby twisting the elongate shaft 12 andthus rotating the distal portion of the elongate shaft 12 and the endeffector 20 attached thereto. As further shown in FIG. 4, the device canalso include an extruded plastic sheath 13 that runs through a majorityof the length of the elongate shaft 12 (not shown in FIG. 4) to guideand protect the control wires 42, 46.

The coupler 44 can include four bores formed therethrough. One of thebores can fixedly mate to the distal end of the first control wire 42,as shown in FIG. 4. Another bore in the coupler 44 can receive a secondcontrol wire 46 used to advance a clip, as will be discussed below. Theremaining two bores in the coupler 44 can fixedly mate to a proximal endof two pull wires (only one pull wire 38 b is shown). As previouslydiscussed with respect to FIG. 2, the distal ends of the pull wires mateto the tangs on the proximal end of each jaw 32 a, 32 b. As a result,when the trigger 24 is pivoted toward the stationary handle 22 tothereby pull the shuttle assembly 40 in a proximal direction, i.e.,toward the back-end of the housing 20, the first control wire 42 ispulled proximally through the elongate shaft 12, thereby pulling thecoupler 44 and the two pull wires attached thereto in a proximaldirection. The opposed jaws 32 a, 32 b will thus move to a closedposition to engage tissue therebetween. Conversely, when the trigger 24is released, the pull wire 42 and coupler 44 can move distally to allowthe jaws 32 a, 32 b to open.

Turning back to FIG. 3, the rotatable knob 26 for rotating the endeffector 30 is also shown. In general, the knob 26 includes a lumen orbore formed therein that receives a proximal end of the first controlwire 42. The lumen is shaped to allow free slidable movement of thefirst control wire 42 along its axis, and to rotationally couple theproximal end of the first control wire 42 to the knob, as will bediscussed in more detail below. As a result, rotation of the knob 26will rotate the control wire 42. The first control wire 42 is preferablyformed from a semi-flexible material, such as a nickel-titanium alloy orstainless steel, which permits the first control wire 42 to transmittorque by rotation without taking a cast, and with minimal whipping. Thefirst control wire 42 also preferably has a sufficiently large diameterto transmit force and torque, yet not so large that it is prevented fromflexing as the elongate shaft 12 is passed through a tortuous lumen.

As previously discussed with respect to FIG. 4, the distal end of thefirst control wire 42 is mated to the coupler 44. Thus, when the knob 26is rotated to rotate the first control wire 42, a torque is generatedwhich causes rotation of the coupler 44, pull wires 38 a (not shown) and38 b, and rigid member 48. The coupler 44 will thus rotate the distalregion of the flexible proximal portion of the elongate shaft 12,thereby rotating the distal portion of the elongate shaft 12, andthereby rotating the end effector 30. As previously indicated, therotatable knob 26 can also be configured to move between a rotationallyresistant and a freely rotatable configuration. Various exemplarytechniques for maintaining the knob 26 in the rotationally resistantposition will be discussed in more detail below with respect to FIGS.6A-7D.

FIG. 3 further illustrates a crank assembly 50 for advancing a clipstored in the distal portion of the elongate shaft 12. The crankassembly 50 is coupled to the crank 28, shown in FIG. 1, which isrotatably coupled to a sidewall of the housing 20. While not shown, asecond crank can be disposed on the opposed side of the housing 20 toallow a user to selectively rotate either knob. Continuing to refer toFIG. 3, the crank assembly 50 includes a set of gears disposed withinthe housing 20 and configured to rotate in response to rotation of thecrank 28. The gears communicate with one another to cause correspondingrotation of a transmission 52 that is mated to a proximal end of thesecond control wire 46. The second control wire 46 extends through theelongate shaft 12 and through a bore formed in the coupler 44, and it isthreadably mated to a threaded bore 48 a formed in the rigid member 48(FIG. 4). The distal end of the second control wire 46 extends into aclip pusher 54, which is shown in FIG. 5 and which is described in moredetail in US. Publication No. 2005/0277954. In general, rotation of thecrank 28 is effective to rotate the second control wire 46. Since thesecond control wire 46 is threadably mated to the rigid member 48, whichis fixed between the proximal and distal portions of the elongate shaft12, the threaded bore 48 a in the rigid member 48 will cause the secondcontrol wire 46 to move distally through the elongate shaft 12, therebyadvancing the pusher 54 in a distal direction. The pusher 54 ispositioned proximal to a series of clips 56 stored within a garage inthe distal portion of the elongate shaft 12, and thus distal movement ofthe pusher 54 will advance the clips 56 through the shaft 12 to positiona distal most clip within the jaws 32 a, 32 b of the end effector 30. Aperson skilled in the art will appreciate that a variety of othertechniques can be used to advance a plurality of clips through theelongate shaft and to position a clip within the jaws.

As indicated above, the present invention provides various techniquesfor engaging an actuator mechanism, such as the rotatable knob 26, tomaintain the end effector 30 at a fixed angular orientation and toprevent “freewheeling” of the knob 26. This position is referred toherein as the rotationally resistant position. This is particularlyadvantageous with endoscopic devices which have a relatively long shaftthrough which the rotational forces must be transferred to rotate theend effector. Moreover, the rotationally resistant position isparticularly useful where the actuator mechanism must be rotated severalturns to position the end effector as desired. In such a situation, theengagement mechanism will prevent the actuator mechanism from“freewheeling” between turns in which the user needs to release andre-grasp the actuator mechanism because the resistance to rotation inthe rotationally resistant position is greater than the return torqueprovided by the angular deflections of the rotation system during use.In an exemplary embodiment, the rotationally resistant position canprovide a minimum resistive torque to resist rotation, yet it can have amaximum torque limit that allows for user positioning (i.e., rotation)in the rotationally resistant position within ergonomic capabilities,.By way of non-limiting example, the minimum resistive torque in therotationally resistant position can be about 0.8 inch-ounces (0.5inch-pounds) and the maximum torque that allows ergonomic manipulationcan be about 5.0 inch-pounds, as applied to an actuation mechanism andcontrol wire of a practical size and materials.

While various techniques can be used to engage the actuator mechanism,in an exemplary embodiment the rotatable knob 26 is slidably movablealong a longitudinal axis of the device 10 between a rotationallyresistant position, in which a portion of the rotatable knob 26 isengaged by a portion of the housing 20 or a component disposed withinthe housing 20, and a freely rotatable position in which the knob 26 isfree to rotate. Various techniques can be used to engage the knob 26 andmaintain the knob 26 in the rotationally resistant position, includingan interference fit, a threaded connection, a snap-lock connection, andother mating techniques known in the art.

As shown in FIG. 6A, knob 26 includes a proximal grasping member 60configured to be grasped by a user, and shaft 62 extending distally fromthe grasping member 60. The shaft 62 is configured to extend through anopening formed in the back end of the housing 20 and, as previouslyexplained, it includes a lumen 64 extending therethrough for slidablyreceiving the proximal end of the first control wire 42. As shown inFIG. 6A, the lumen 64 can be keyed to allow free slidable movement ofthe first control wire 42, yet to couple rotation of the first controlwire 42 to the rotatable knob 26. The proximal end 42 a of the firstcontrol wire 42 is shown in FIG. 6B, and as shown the proximal end 42 ais bent into a shepherd's crook to allow the keyed lumen 64 in the knob26 to engage the first control wire 42. As further shown in FIG. 6A, theshaft 62 of the knob 26 is split longitudinally such that the shaft 62includes first and second halves 62 a, 62 b that are deflectablerelative to one another. The shaft 62 can also optionally include one ormore surface features formed thereon and configured to help resistrotation of the knob 26, as will be discussed below. In the illustratedembodiment, the first and second halves 62 a, 62 b each include aprotrusion 65 a, 65 b formed thereon. A person skilled in the art willappreciate that the surface features can have a variety of otherconfigurations, such a grooves, teeth, ridges, etc., and that variousother techniques instead of surface features can optionally be used.

In use, the split shaft 62 and the protrusions 65 a, 65 b allow thehousing 20 to engage and resist rotation of the knob 26. In particular,the interior portion of the housing 20 can be molded or otherwise shapedto have walls formed therein that define one or more openings forreceiving the shaft 62 of the knob 26 therethrough. As shown in FIG. 6D,the interior walls define a first opening 66 that receives a proximalportion of the shaft 62, and a second opening 68 that receives thedistal end of the shaft 62. The first opening 66 can function to merelyalign the shaft 62 and allow free slidable movement thereof along theaxis of the shaft 62. The second opening 68, on the other hand, can besized to engage the shaft 62 when the shaft 62 is positioned therein,thereby engaging and preventing free wheeling of the knob 26.

The knob 26 can be moved to the rotationally resistant position bysliding the knob 26 from a proximal position, shown in FIG. 6D, to adistal position to position the distal end of the shaft 62 within thesecond opening 68, a shown in FIG. 6E. The split configuration of theshaft 62 will allow the halves 62 a, 62 b of the shaft 62 to becompressed toward one another to allow the second opening 68 to engagethe shaft 62. The protrusions 65 a, 65 b can be received withincorresponding grooves or cut-outs formed in the second opening 68 toallow the second opening 68 to resist rotation of the shaft 62. Across-sectional view of the second opening 68 is shown in FIG. 6C, whichillustrates opposed cut-outs or grooves 68 a, 68 b formed in the secondopening 68 for seating the protrusions 65 a, 65 b. While only a singlepair of grooves, 68 a and 68 b are shown, the knob 26 can includemultiple pairs of grooves around the circumference of opening 68 to givea finer resolution of resistive positions.

When desired, the knob 26 can be moved to the freely rotatable position,shown in FIG. 6D, by pulling the knob 26 in a proximal direction toremove the distal end of the shaft 62 from the second opening 68.Alternatively, the trigger 24 can be pivoted toward the stationarymember 22 to release the knob 26 from the rotationally resistantposition. As shown in FIG. 6F, the proximal portion 24 a of the trigger24 will abut against the distal end of the shaft 62, thereby forcing theshaft 62 in a proximal direction, and thus moving the knob 26 proximallyto the freely rotatable position. As shown in FIGS. 6D-6F, a compressionspring 70 can optionally be disposed around the shaft 62 of the knob 26to bias the knob 26 toward the proximal, freely rotatable position. Thecompression spring 70 will also help return the knob 26 to the freelyrotatable position when the trigger 24 is actuated to release the knob26.

A person skilled in the art will appreciate that various othertechniques can be used to allow the second opening 68 to engage theproximal end of the shaft 62 on the knob 26. For example, the shaft 62and opening 68 can include a ratchet mechanism, or teeth andprotrusions, that allow the opening 68 to engage and prevent rotation ofthe shaft 62. Such a configuration is particularly advantageous as itcould be configured to allow the user the rotate the knob 26 to adesired degree, e.g., dial the knob to a particular position with apositional resolution being defined by the number and spacing of thedetents. In other embodiments, other regions of the housing 20 can beconfigured to engage the shaft 62 or other portions of the knob 26. Forexample, the first opening 66 can engage the shaft 62, or alternativelythe opening in the proximal-most or back end of the housing 20 can beconfigured to engage the proximal grasping member 60 of the knob 26.

FIGS. 7A-7C illustrate one embodiment of a knob 126 having a proximalgrasping portion 160 that is configured to be engaged by an opening 172formed in the back of the housing 120. While the knob 126 is shown as aseparate embodiment from the knob 26 described with respect to FIGS.6A-6, the features of each knob 26, 126 can be used in combination withone another to provide a more secure rotationally resistantconfiguration. In this embodiment, rather than configuring the distalend of the shaft to be engaged by an opening defined by walls formedwithin the housing, the proximal grasping member 160, or a proximal endof the shaft 162, can be configured to be engaged by an opening 172formed in the back end of the housing 120. In particular, as shown inFIG. 7A, an enlarged diameter region or a flange 163 can be formedaround the proximal-most end of the shaft 162, and thus adjacent to thegrasping member 160. The opening 172 in the back side of the housing 120can be sized to engage the enlarged diameter region or flange 163 toprevent rotation of the knob 126. Thus, in use, the knob 126 can bemoved between a proximal, freely rotatable position shown in FIG. 7B, inwhich the enlarged diameter region or flange 163 is positioned distal ofthe opening 172 in the housing 120, and a distal, rotationally resistantposition shown in FIG. 7C, in which the enlarged diameter region orflange 163 is positioned within and engaged by the opening 172 in thehousing 120. As further shown in FIGS. 7A-7C, the knob 126 can alsoinclude a second flange 167 formed distal of the enlarged diameterregion or flange 163, and configured to be positioned between theopening 172 in the housing 120 and the first opening 166 formed by thewalls within the housing 120. The second flange 167 will prevent theknob 126 from being removed from the housing 120 in use. While notshown, the enlarged diameter region or flange 163 and/or the opening 172in the housing 120 can also include surface features, such as thosepreviously described, to further prevent rotation of the knob 126relative to the housing 120 when the knob 126 is in the rotationallyresistant position. As yet another alternative, the enlarged diameterregion or flange 163 can be replaced by an O-ring or similar deformableelement that is formed on, mated to, or resides in a groove in the knob126 at the location of the enlarged diameter region or flange. The knob126 can also be released from the rotationally resistant position bypulling the knob 126 proximally or by actuating the trigger 124, aspreviously described and as shown in FIG. 7D.

In use, the various devices disclosed herein can be insertedtranslumenally, i.e., through a natural orifice, or through anotheraccess port. Referring to the device of FIG. 1, for example, the shaft12 can be delivered through an endoscope or other endoscopic deliverydevice. The trigger 24 is preferably actuated to move the jaws 32 a, 32b to the closed position for insertion. As shown in FIG. 1, the trigger24 and stationary member 22 can each include a hook 24 h, 22 h formedthereon for locking the trigger 24 in the actuated position. Once thejaws 32 a, 32 b are positioned at the desired location, the trigger 24can be released to open the jaws 32 a, 32 b. The jaws 32 a, 32 b can bepositioned through movement of the coil shaft 12 and by rotating theknob 26 to position tissue to be clipped between the jaws 32 a, 32 b. Aspreviously explained, rotation of the knob 26 will torque the firstcontrol member 42, thereby rotating the coupling member 44 (FIG. 4), andthus the distal region of the flexible proximal portion of the shaft 12.As a result, the distal portion of the shaft 12 and the end effector 30will rotate. In order to maintain the knob 26 in the rotated position,either during successive turns of the knob 26 or once the knob 26 isrotated to a desired degree, the knob 26 can be moved distally to therotationally resistant position, in which the knob 26 is resistant torotation and the end effector 30 is maintained at a desired angularorientation. The trigger 24 can then be actuated again, i.e., movedtoward the stationary member 22, to close the jaws 32 a, 32 b and engagetissue therebetween. As the trigger 24 is actuated, it will force theknob 26 into the freely rotatable position, thereby allowing freerotation of the knob 26 and releasing any torque applied to the firstcontrol wire 42. The crank 28 is then turned to advance a clip into thejaws 32 a, 32 b, which can function as an anvil to deform the clip. Thetrigger 24 can then be released once again to release the clip andtissue from the jaws 32 a, 32 b, and the device 10 can be removed.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces, and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning and/or replacement, and reassembly. Use of such techniques, andthe resulting reconditioned device, are all within the scope of thepresent application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility. It is preferred that the device is sterilized. This can bedone by any number of ways known to those skilled in the art includingbeta or gamma radiation, ethylene oxide, steam.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1. An endoscopic device, comprising: a flexible elongate shaft havingproximal and distal ends; an end effector coupled to the distal end ofthe elongate shaft; and a housing coupled to the proximal end of theelongate shaft, the housing including an actuator mechanism associatedwith a distal end of the elongate shaft such that rotation of theactuator mechanism is effective to rotate the distal end of the elongateshaft and thereby rotate the end effector, the actuator mechanism beingmovable between a freely rotatable position and a rotationally resistantposition in which the actuator mechanism is resistant to rotation. 2.The device of claim 1, wherein the actuator mechanism comprises arotatable knob.
 3. The device of claim 2, wherein the rotatable knob isrotatably disposed within an opening formed in the housing and isslidably movable relative to the housing along a longitudinal axis ofthe device.
 4. The device of claim 3, wherein sliding movement of theknob along the longitudinal axis is effective to move the knob betweenthe freely rotatable position and the rotationally resistant position.5. The device of claim 4, wherein the housing includes an engagementmechanism formed therein and configured to releasably engage a portionof the knob when the knob is in the rotationally resistant position. 6.The device of claim 5, wherein the engagement mechanism comprises aflange formed within the housing and configured to frictionally engage aportion of the knob when the knob is in the rotationally resistantposition.
 7. The device of claim 5, wherein the engagement mechanismcomprises a flange formed within the housing and configured to engagedetents formed on a portion of the knob when the knob is in therotationally resistant position.
 8. The device of claim 1, wherein theactuator mechanism includes a shaft having at least an end portion thatis split into first and second halves, and wherein the housing includesan opening located therein and configured to receive and engage thefirst and second halves to maintain the actuator mechanism in therotationally resistant position.
 9. The device of claim 8, wherein atleast one of the first and second halves includes at least one surfacefeature formed thereon, and wherein the opening includes at least onegroove formed therein and configured to receive the at least one surfacefeature to prevent rotation of the actuator mechanism.
 10. The device ofclaim 2, wherein the rotatable knob includes a deformable element andwherein the housing includes an opening located therein and configuredto receive and engage the deformable element to maintain the actuatormechanism in the rotationally resistant position.
 11. The device ofclaim 1, wherein, when the actuator mechanism is in the rotationallyresistant position, a resistance to rotation provided by the housing tothe actuator mechanism is between about 0.5 and 5.0 inch pounds.
 12. Thedevice of claim 1, wherein, when the actuator mechanism is in therotationally resistant position, a resistance to rotation provided bythe housing to the rotation mechanism is about 1.2 inch pounds.
 13. Thedevice of claim 1, further comprising a biasing element coupled to theactuator mechanism and adapted to bias the actuator mechanism to thefreely rotatable position.
 14. The device of claim 1, wherein theactuator mechanism and the distal end of the elongate shaft areassociated by a flexible control wire extending through the elongateshaft between the actuator mechanism and the distal end of the elongateshaft.
 15. The device of claim 14, wherein rotation of the actuatormember is effective to torque the flexible control wire and therebytorque the distal end of the elongate shaft to rotate the end effector.16. The device of claim 1, wherein the housing includes a graspingmechanism movably coupled thereto, and wherein movement of the graspingmechanism from a first position to a second position is configured tomove the actuator mechanism from the rotationally resistant position tothe freely rotatable position.
 17. The device of claim 16, wherein theend effector includes opposed jaws and wherein movement of the graspingmechanism from the first position to the second position is effective toclose the opposed jaws.
 18. A surgical fastener applying device,comprising: a flexible elongate shaft having proximal and distal ends;an end effector coupled to the distal end of the elongate shaft andincluding opposed jaws adapted to engage tissue therebetween and toapply at least one fastener to the engaged tissue; and a housing coupledto the proximal end of the elongate shaft and having an actuatormechanism rotatably coupled thereto, the actuator mechanism beingslidably movable between a first position, in which rotation of theactuator mechanism is effective to rotate a distal end of the elongateshaft to thereby rotate the end effector, and a second position, inwhich the actuator mechanism is resistant to rotation.
 19. The device ofclaim 18, wherein the housing includes an engagement mechanism formedtherein and configured to releasably engage the actuator mechanism tomaintain the actuator mechanism in the second position.
 20. The deviceof claim 18, further comprising a grasping mechanism movably coupled tothe housing and configured to move the actuator mechanism from thesecond position to the first position.
 21. A method for rotating an endeffector on an endoscopic surgical device, comprising: rotating anactuator mechanism on a housing of an endoscopic surgical device torotate a distal end of an elongate shaft extending from the housing, thedistal end of the elongate shaft having an end effector coupled theretothat rotates therewith; and sliding the actuator mechanism along alongitudinal axis of the device to move the actuator mechanism to arotationally resistant position, wherein the actuator mechanism,elongate shaft, and end effector are maintain in a rotationallyresistant position.
 22. The method of claim 21, wherein the distal endof the elongate shaft and actuator mechanism are coupled by a flexiblecontrol wire, and wherein rotating the actuator mechanism torques theflexible control wire to cause the distal end of the elongate shaft andthe end effector coupled thereto to rotate.
 23. The method of claim 22,further comprising sliding the actuator mechanism in an oppositedirection along a longitudinal axis of the device to move the actuatormechanism to a freely rotatable position in which any torque on theflexible control wire is released.
 24. The method of claim 21, furthercomprising moving a grasping mechanism coupled to the housing, thegrasping mechanism moving the actuator mechanism from the rotationallyresistant position to a freely rotatable position.
 25. The method ofclaim 21, wherein a resistive torque applied to the actuator mechanismin the rotationally resistant position is between about 0.5 and 5.0 inchpounds.
 26. The method of claim 21, wherein a resistive torque appliedto the actuator mechanism in the rotationally resistant position isabout 1.2 inch pounds.
 27. The method of claim 21, wherein theendoscopic surgical device is inserted through a body lumen.
 28. Themethod of claim 21, further including the step of sterilizing theendoscopic surgical device after at least one use.